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Recruitment status Terminated
Unique ID issued by UMIN UMIN000019214
Receipt No. R000022209
Scientific Title Pharyngeal cannulae as a new oxygen delivery method; comparison to nasal vannulae
Date of disclosure of the study information 2015/10/05
Last modified on 2019/01/24

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Basic information
Public title Pharyngeal cannulae as a new oxygen delivery method; comparison to nasal vannulae
Acronym Pharyngeal cannulae as a new oxygen delivery method
Scientific Title Pharyngeal cannulae as a new oxygen delivery method; comparison to nasal vannulae
Scientific Title:Acronym Pharyngeal cannulae as a new oxygen delivery method
Region
Japan

Condition
Condition Hypoxia during upper gastrointestinal endoscopy in sedated patients
Classification by specialty
Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 During sedation for upper gastrointestinal endoscopy, oxygen supplementation with nasal cannulae (NC) is frequently necessary to prevent hypoxia. A mannequine study we previously performed showed pharyngeal cannulae (PC) provided higher oxygen consentration than NC. This study is aimed to show PC can privide higher oxygen fraction than NC in real patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Fraction of inspired oxygen during oxygen delivery via PC or NC, which is mearsured with direct sampling of tracheal gas by cricothyroid ligament puncture catheter
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Oxygen is administrated via a catherter inserted from nose to pharyngeal space at 4 L/min. After preoxygenation (more than 5 minutes), FIO2 is measured for 1 minute by sampling from tracheal catherter. Second measurement is performed in the same way.
Interventions/Control_2 Oxygen is administrated via a nasal cannula at 4L/min. After preoxygenation (more than 5 minutes), FIO2 is measured for 1 minute by sampling from tracheal catherter. Second measurement is performed in the same way.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria Patients who were inserted minitracheostomy tubes after extubation of oral endotracheal tubes would be recruited into this study. Participants needs to be awake and be able to understand and consent to this study.
Key exclusion criteria Exclusion criteria includes patients with anatomical abnormality of nose and pharynx, respiratory diseases, unstable circulatory status, severe hypoxia. In addition, patients who are judged to unsuitable to this study would be also excluded.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shunsuke Takaki
Organization Yokohama City University Hospital
Division name Department of Anesthesiology and Intensive Care Unit
Zip code
Address 3-9, Fukura, Kanazawa-ku Yokohama-shi, Kanagawa, 236-0004, Japan
TEL 81457872918
Email anesthes@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shunsuke Takaki
Organization Yokohama City University Hospital
Division name Department of Anesthesiology and Intensive Care Unit
Zip code
Address 3-9, Fukura, Kanazawa-ku Yokohama-shi, Kanagawa, 236-0004, Japan
TEL 81457872918
Homepage URL
Email anesthes@yokohama-cu.ac.jp

Sponsor
Institute Department of Anesthesiology and Intensive Care Unit, Yokohama City University Hospital
Institute
Department

Funding Source
Organization Department of Anesthesiology, Yokohama City University Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 横浜市立大学附属病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2015 Year 10 Month 05 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2015 Year 09 Month 17 Day
Date of IRB
Anticipated trial start date
2015 Year 10 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 10 Month 02 Day
Last modified on
2019 Year 01 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022209

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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